The European Medicines Agency (EMA) has given marketing authorisation to GlaskoSmithKline for breast cancer drug Tyverb to be used in combination with Roche’s Herceptin in the European Union.
The drugs combination is for treatment of patients with HER2-positive metastatic breast cancer whose disease has progressed on a Herceptin-containing regimen.
Approximately 25% to 30% of women with metastatic breast cancer have tumours which over-express the HER2-positive protein.
Patients with this type of breast cancer have limited targeted therapy options available to them after Herceptin-based therapy has failed to halt disease progression. This new drugs combination offers a chemotherapy-free treatment option.
GlaxoSmithKline UK medical director Dr Pim Kon said, "We believe this new combination therapy has the potential to make a meaningful impact on the care and survival of women in this breast cancer population."
The two drugs work together by targeting the same HER2 receptor at different points – above and below the cell membrane.
Tyverb, a monoclonal antibody, binds to the ‘above’ domain of the HER2 receptor, while Herceptin inhibits tyrosine kinase activity of the same HER2 receptor which is ‘below’.
The EMA approval is based on findings from a Phase III study of Tyverb plus Herceptin versus Tyverb monotherapy in patients with HER2-positive metastatic breast cancer, whose disease had progressed on a Herceptin-containing regimen.
The combination of Tyverb plus Herceptin was associated with an 8.3 month increase in median overall survival versus Tyverb therapy alone.
Image: Approximately 25% to 30% of women with metastatic breast cancer have tumours which over-express the HER2-positive protein. Photo courtesy of Maxwell Hamilton.